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NCT02146690 Clinical Trial

Effect of Osteopathic Manipulative Treatment on Reduction of Pain in Complicated Newborns: RCT

Prematurity Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02146690
Other study ID # NEO-Pa 2
Secondary ID
Status Recruiting
Phase N/A
First received May 20, 2014
Last updated September 15, 2014
Start date June 2014
Est. completion date November 2015

Study information
Verified date September 2014
Source European Institute for Evidence Based Osteopathic Medicine
Contact Francesco Cerritelli
Phone +393394332801
Email francesco.cerritelli@ebom.it
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial Summary

The aim of the present 3 armed placebo control parallel group randomized control trial is to explore the extent to which osteopathic manipulative treatment is effective in reducing pain in a population of complicated newborns.

Recruitment information / eligibility
Status Recruiting
Enrollment 225
Est. completion date November 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender Both
Age group 26 Weeks to 40 Weeks
Eligibility Inclusion Criteria:

- newborns born in the same hospital

- either gender

- diagnosis of any pathological/clinical medical condition

Exclusion Criteria:

- lack of guardian consent

- newborn transferred to/from other hospital

- lack of any of the inclusion criteria

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• osteopathic manipulative treatment

• sham therapy

• usual care

Locations
Country Name City State
Italy Pescara Civil Hospital Pescara

Sponsors (1)
Lead Sponsor Collaborator
European Institute for Evidence Based Osteopathic Medicine

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Other Neonatal Intensive Care Unit cost participants will be followed for the duration of hospital stay, an expected average of 4 weeks No
Primary baseline changes in pain score using Premature Infant Pain Profile baseline and end of hospitalization, expected hospitalization 4 weeks No
Secondary Length of stay in days participants will be followed for the duration of hospital stay, an expected average of 4 weeks No
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